New Standards On Human Test Data Needed

Two leading medical journals have found weaknesses in how the Food and Drug Administration approves cardiovascular medical devices. The FDA says it is developing guidelines that will set tougher scientific standards for testing medical devices seeking approval. Manufacturers should know exactly what is expected of them and then the FDA should make sure they comply. The FDA is beginning to recognize the steps necessary to see that this happens. The data produced by the trials must be reliable. If the data aren’t reliable, the risks for server problems greatly increase.


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